Table 1.

Principal inclusion and exclusion criteria for ODYSSEY FH I, FH II, and HIGH FH

Principal inclusion criteria for all three studies
Patients with heFH who are not adequately controlleda with a maximally-tolerated stable daily dose of statinb for at least 4 weeks prior to the screening visit, with or without other LLT
Principal exclusion criteria
Not on a stable dose of LLT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit or from screening to randomization
Currently taking a statin that is not simvastatin, atorvastatin or rosuvastatin taken daily at a registered dose
Receiving daily doses above atorvastatin 80 mg, rosuvastatin 40 mg or simvastatin 40 mg (except for patients on simvastatin 80 mg for more than 1 year, who are eligible)
Use of fibrates, other than fenofibrate, within 6 weeks of the screening visit
Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening visit
Known history of homozygous FH
FH I and II	HIGH FH
History of documented CVD and LDL-C <70 mg/dL (<1.81 mmol/L) at the screening visit Without history of documented CVD and LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit	LDL-C <160 mg/dL (<4.14 mmol/L) at the screening visit AND patient only on statin monotherapy without additional LLT

CVD cardiovascular disease, FH familial hypercholesterolemia, heFH heterozygous familial hypercholesterolemia, LDL-C low-density lipoprotein cholesterol, LLT lipid-lowering therapy, MI myocardial infarction

^aFH I and II: not adequately controlled defined as an LDL-C ≥70 mg/dL at the screening visit in patients with a history of documented CVD OR LDL-C ≥100 mg/dL at the screening visit in patients without a history of documented CVD. HIGH FH: not adequately controlled defined as an LDL-C ≥160 mg/dL at the screening visit

^bMaximally-tolerated statin dose defined as: the highest tolerable registered dose of daily statin currently administered to the patient, that is rosuvastatin 20 mg or 40 mg daily; atorvastatin 40 mg or 80 mg daily; simvastatin 80 mg daily (if already on this dose for >1 year). Patients who are not able to be on any of the above statin doses should be treated with the dose of daily atorvastatin, rosuvastatin, or simvastatin which is considered appropriate for the patient, according to the investigator’s judgment